Ascendis Pharma’s FDA review of Achondroplasia drug gets 3-month delay
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
CD388 is administered as a single 450-milligram subcutaneous dose in adults and adolescents
The viewer aims to help radiologists work smarter, faster, and more collaboratively, while reducing IT complexity and freeing up valuable clinical time
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
Owlet’s push comes as parents demand smarter, more dependable nursery tech
The Signia Circular Stapler is the only circular stapler on the market with integrated leak testing and features designed to minimize risk
The trial tested six injectable doses and three oral doses over as long as 36 weeks
The deal accelerates GE HealthCare’s digital transformation, expanding its reach into outpatient care and enterprise imaging—a $2 billion-plus growth market
Globally, Abbott has received reports of 736 severe adverse events linked to the issue, including seven deaths (none in the US)
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